Diabetes mellitus is a metabolic disorder in which the ability to utilize glucose is partly or completely lost.
In the treatment of diabetes mellitus, many varieties of insulin formulations. Normally, insulin formulations are administered by subcutaneous injection.
Another peptide of interest in the treatment of diabetes is amylin. The actions of amylin in relation to diabetes are: Reduction of food-intake leading to lower body-weight, slower gastric emptying, smoothening of post-prandial glucose profiles, and reduction in the excessive diabetic glucagon release (A. Young, Amylin: Physiology and Pharmacology, Academic Press (2005)). By and large the actions of amylin are mediated via identified CNS receptors rather than directly on the target organs.
Human amylin is a 37 amino acid long peptide which has physico-chemical properties that make its use as a drug troublesome. In particular, it has a tendency to fibrillate ex-vivo and become ineffective due to precipitation. There is currently on the marked a drug product called Symlin® containing an analog of human amylin (pramlintide) where the three amino acids in positions 25, 28 and 29 each are substituted to proline. This improves substantially the fibrillating tendency. However, even pramlintide is difficult to keep in solution at neutral pH and it is therefore provided in an acidic solution i.e. Symlin®. When a drug is administered at acidic pH there is a risk that it will cause local irritation in the patient.
It would be useful to provide a pharmaceutical composition comprising an amylin peptide in a stable solution at physiological pH.